Postpartum HemorrhageUBTNCT02430155
Balloon Tamponade for Atonic Primary Postpartum Hemorrhage
A study testing Bakri balloon and Condom loaded foley's catheter in people with Postpartum Hemorrhage, run by Assiut University.
Trial summary
Postpartum hemorrhage (PPH) is responsible for around 25% of maternal mortality worldwide reaching as high as 60% in some countries.PPH can also be a cause of long-term severe morbidity, and approximately 12% of women who survive PPH will have severe anemia. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Postpartum Hemorrhage
- What is being tested?
- Bakri balloon and Condom loaded foley's catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- Jul 2014to 4 Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women who accept to participate (either the patient or her first-kin if she is unconscious)
- Primary atonic postpartum hemorrhage
Who cannot join
- Traumatic postpartum hemorrhage
- With any suspected (e.g. prolonged rupture of membranes) or clinical evidence of infection
- Pre eclampsia.
- Diabetes mellietus(DM) with pregnancy
- History of Deep venous thrombosis (DVT) or other thromboembolic complication
- Rheumatic heart patients
About this study
Official title: Comparison of Condom-Loaded Foley's Catheter Versus Bakri Balloon for Treatment of Primary Postpartum Hemorrhage: A Randomized Controlled Trial
Postpartum hemorrhage (PPH) is responsible for around 25% of maternal mortality worldwide reaching as high as 60% in some countries.PPH can also be a cause of long-term severe morbidity, and approximately 12% of women who survive PPH will have severe anemia.
Postpartum hemorrhage has been defined as blood loss in excess of 500 ml in a vaginal birth and in excess of 1 L in a cesarean delivery.For clinical purposes, any blood loss that has the potential to produce hemodynamic instability should be considered a PPH. However, clinical estimates of blood loss are often inaccurate. Primary (immediate) PPH occurs within the first 24 hours after delivery and approximately 70% of these cases are due to uterine atony. Furthermore, uterine tony is defined as the failure of the uterus to contract adequately after the child is born.
Read more
Guidelines for the management of postpartum hemorrhage (PPH) involve a stepwise approach including the exclusion of retained products of conception and genital tract trauma. Uterine atony, which is the most common cause, the management of uterine atony is an established stepwise protocol that in many international guidelines.
Uterine massage is recommended for the treatment of PPH. Initiate uterine massages soon as excessive bleeding/uterine atony is identified. Intravenous oxytocin alone still is the recommended uterotonic drug for the treatment of PPH.
If intravenous oxytocin is unavailable or if the bleeding does not respond to oxytocin, intravenous ergometrine, oxytocin-ergometrine fixed dose or a prostaglandin drug (including sublingual misoprostol, 600 mcg) should be given. The use of intrauterine balloon tamponade is recommended for the treatment of primary PPH due to uterine atony in women who do not respond to uterotonics or if uterotonics are not available.
Since 1983, when Goldrath published evidence that inserting a Foley catheter in the uterus and inflating it with water could achieve tamponade, case series and other studies have suggested that various uterine balloon tamponade(UBT) devices may be effective in treating PPH. The studies used various types of UBT devices, including a condom catheter, a Foley catheter, the Sengstaken-Blakemore Esophageal Tube, the Rusch Balloon, and the Bakri Uterine Balloon. In 2007, a systematic review of treatment options for PPH found that 84% success rate of UBT does not significantly vary from surgical treatment outcomes.The World Health Organization (WHO), the International Federation of Gynecology and Obstetrics (FIGO), the American College of Obstetricians and Gynecologists(ACOG), the Royal College of Obstetricians and Gynecologists(RCOG), and the International Confederation of Midwives (ICM) recognize balloon tamponade as a method that could significantly improve the management intractable PPH, especially in low-resource areas.
In 2012, WHO updated the guidelines for the management of PPH and retained placenta to include: "The use of intrauterine balloon tamponade is recommended for the treatment of PPH due to uterine atony. This recommendation is now stronger than the previous guidelines. It can be used for women who do not respond to uterotonics or if uterotonics are not available. This procedure potentially can avoid surgery and is appropriate while awaiting transfer to a higher-level facility".Furthermore, FIGO included UBT as a recommended second-line intervention for the treatment of PPH in their updated guidelines issued in 2012.
Bakri first published the concept of intrauterine balloon technology in the management of hemorrhage secondary to placenta praevia-accreta during caesarean section with or without bilateral hypo gastric arterial ligation.In 2006, the ACOG Practice Bulletin, published by the American College of Obstetricians and Gynecologists, made mention of the Bakri postpartum balloon for its specifically tailored design that enables conservative management of uterine bleeding in cases of uterine atony and other causes of PPH.
The idea of using a condom as a balloon tamponade was first generated and evaluated in Bangladesh by Sayeba Akhter to fill a need and in response to the high cost of commercially available UBT devices.
- Conditions
- Postpartum Hemorrhage
- Being tested
- Bakri balloon, Condom loaded foley's catheter
- Keywords
- condom-loaded Foley's catheter, Bakri balloon, primary atonic postpartum hemorrhage
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bakri balloonDevice
is a 100% silicone construction, dual channel balloon catheter specifically designed and approved by FDA for intrauterine placement in cases of PPH. The Bakri balloon contains no latex, and therefore can be safely used in patients with latex allergies
Condom loaded foley's catheterDevice
Under aseptic precautions a sterile rubber catheter was inserted within the condom and tied near the mouth of the condom by a silk thread.
| Study group | Role | What they receive |
|---|---|---|
| Bakri balloon group | Active comparator | The women in this group will be managed by Bakri balloon Receives: Device: Bakri balloon |
| Condom loaded Foley's catheter group | Active comparator | The women in this group will be managed by condom loaded Foley's catheter Receives: Device: Condom loaded foley's catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who need surgical intervention to stop the bleeding
Measured: 1 year
Secondary outcomes (8)
Time between insertion and stoppage of bleeding (minutes)
Measured: 1 year
Number of patients who need a blood transfusion
Measured: 1 year
Number of patients who developed fever
Measured: 1 year
The amount of blood loss (ml) after application of the balloon
Measured: 1 year
Number of patients who referred to Intensive care unit
Measured: 1 year
Number of patients who developed disseminated intravascular coagulopathy
Measured: 1 year
Duration (minutes) of bleeding after deflation of the balloon
Measured: 1 year
amount of bleeding (ml) after deflation of the balloon
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2015 (estimated)
- Study startJul 2014
- Primary completion1 Jul 2015
- Study completion4 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postpartum HemorrhageStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Mamdouh Shaaban, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02430155
- Sponsor's protocol ID
- Uterine balloon tamponade
- Acronym
- UBT
- Status last verified
- Nov 2017
- First submitted
- 24 Mar 2015
- Last updated
- 22 Nov 2017
- Results posted
- No
Publications
Kellie FJ, Wandabwa JN, Mousa HA, Weeks AD. Mechanical and surgical interventions for treating primary postpartum haemorrhage. Cochrane Database Syst Rev. 2020 Jul 1;7(7):CD013663. doi: 10.1002/14651858.CD013663.
PubMed 32609374
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Condom-Loaded Foley's Catheter Versus Bakri Balloon for Treatment of Primary Postpartum Hemorrhage: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02430155
- Acronym / sponsor ID
- UBT / Uterine balloon tamponade
- Conditions
- Postpartum Hemorrhage
- Keywords
- condom-loaded Foley's catheter, Bakri balloon, primary atonic postpartum hemorrhage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jul 2014 (actual)
- Primary completion
- 1 Jul 2015 (actual)
- Study completion
- 4 Mar 2016 (actual)
- First posted
- 30 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Postpartum hemorrhage (PPH) is responsible for around 25% of maternal mortality worldwide reaching as high as 60% in some countries.PPH can also be a cause of long-term severe morbidity, and approximately 12% of women who survive PPH will have severe anemia.
Postpartum hemorrhage has been defined as blood loss in excess of 500 ml in a vaginal birth and in excess of 1 L in a cesarean delivery.For clinical purposes, any blood loss that has the potential to produce hemodynamic instability should be considered a PPH. However, clinical estimates of blood loss are often inaccurate. Primary (immediate) PPH occurs within the first 24 hours after delivery and approximately 70% of these cases are due to uterine atony. Furthermore, uterine tony is defined as the failure of the uterus to contract adequately after the child is born.
Guidelines for the management of postpartum hemorrhage (PPH) involve a stepwise approach including the exclusion of retained products of conception and genital tract trauma. Uterine atony, which is the most common cause, the management of uterine atony is an established stepwise protocol that in many international guidelines.
Uterine massage is recommended for the treatment of PPH. Initiate uterine massages soon as excessive bleeding/uterine atony is identified. Intravenous oxytocin alone still is the recommended uterotonic drug for the treatment of PPH.
If intravenous oxytocin is unavailable or if the bleeding does not respond to oxytocin, intravenous ergometrine, oxytocin-ergometrine fixed dose or a prostaglandin drug (including sublingual misoprostol, 600 mcg) should be given. The use of intrauterine balloon tamponade is recommended for the treatment of primary PPH due to uterine atony in women who do not respond to uterotonics or if uterotonics are not available.
Since 1983, when Goldrath published evidence that inserting a Foley catheter in the uterus and inflating it with water could achieve tamponade, case series and other studies have suggested that various uterine balloon tamponade(UBT) devices may be effective in treating PPH. The studies used various types of UBT devices, including a condom catheter, a Foley catheter, the Sengstaken-Blakemore Esophageal Tube, the Rusch Balloon, and the Bakri Uterine Balloon. In 2007, a systematic review of treatment options for PPH found that 84% success rate of UBT does not significantly vary from surgical treatment outcomes.The World Health Organization (WHO), the International Federation of Gynecology and Obstetrics (FIGO), the American College of Obstetricians and Gynecologists(ACOG), the Royal College of Obstetricians and Gynecologists(RCOG), and the International Confederation of Midwives (ICM) recognize balloon tamponade as a method that could significantly improve the management intractable PPH, especially in low-resource areas.
In 2012, WHO updated the guidelines for the management of PPH and retained placenta to include: "The use of intrauterine balloon tamponade is recommended for the treatment of PPH due to uterine atony. This recommendation is now stronger than the previous guidelines. It can be used for women who do not respond to uterotonics or if uterotonics are not available. This procedure potentially can avoid surgery and is appropriate while awaiting transfer to a higher-level facility".Furthermore, FIGO included UBT as a recommended second-line intervention for the treatment of PPH in their updated guidelines issued in 2012.
Bakri first published the concept of intrauterine balloon technology in the management of hemorrhage secondary to placenta praevia-accreta during caesarean section with or without bilateral hypo gastric arterial ligation.In 2006, the ACOG Practice Bulletin, published by the American College of Obstetricians and Gynecologists, made mention of the Bakri postpartum balloon for its specifically tailored design that enables conservative management of uterine bleeding in cases of uterine atony and other causes of PPH.
The idea of using a condom as a balloon tamponade was first generated and evaluated in Bangladesh by Sayeba Akhter to fill a need and in response to the high cost of commercially available UBT devices.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bakri balloon group | Active comparator | Device: Bakri balloonThe women in this group will be managed by Bakri balloon |
| Condom loaded Foley's catheter group | Active comparator | Device: Condom loaded foley's catheterThe women in this group will be managed by condom loaded Foley's catheter |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Women who accept to participate (either the patient or her first-kin if she is unconscious)
- Primary atonic postpartum hemorrhage
Key exclusion criteria (6 listed)
- Traumatic postpartum hemorrhage
- With any suspected (e.g. prolonged rupture of membranes) or clinical evidence of infection
- Pre eclampsia.
- Diabetes mellietus(DM) with pregnancy
- History of Deep venous thrombosis (DVT) or other thromboembolic complication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bakri balloonis a 100% silicone construction, dual channel balloon catheter specifically designed and approved by FDA for intrauterine placement in cases of PPH. The Bakri balloon contains no latex, and therefore can be safely used in patients with latex allergies | Device | Bakri balloon group |
| Condom loaded foley's catheterUnder aseptic precautions a sterile rubber catheter was inserted within the condom and tied near the mouth of the condom by a silk thread. | Device | Condom loaded Foley's catheter group |
Primary outcome
Number of patients who need surgical intervention to stop the bleeding
Time frame: 1 year
8 secondary outcomes
Time between insertion and stoppage of bleeding (minutes)
Time frame: 1 year
Number of patients who need a blood transfusion
Time frame: 1 year
Number of patients who developed fever
Time frame: 1 year
The amount of blood loss (ml) after application of the balloon
Time frame: 1 year
Number of patients who referred to Intensive care unit
Time frame: 1 year
Number of patients who developed disseminated intravascular coagulopathy
Time frame: 1 year
Duration (minutes) of bleeding after deflation of the balloon
Time frame: 1 year
amount of bleeding (ml) after deflation of the balloon
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2017.
- Derived from this study: PubMed 32609374Kellie FJ, Wandabwa JN, Mousa HA, Weeks AD. Mechanical and surgical interventions for treating primary postpartum haemorrhage. Cochrane Database Syst Rev. 2020 Jul 1;7(7):CD013663. doi: 10.1002/14651858.CD013663.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Bakri balloon and Condom loaded foley's catheter in people with Postpartum Hemorrhage, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients who need surgical intervention to stop the bleeding (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02430155, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2017.